Scientific evidence does not show that D&X is a safe and necessary procedure.

By Clarke D. Forsythe —
November 6, 2006

One of the reasons why American medicine is the envy of the world is that it has increasingly emphasized “evidence-based medicine” over the last 50 years. This means that new medical techniques, drugs, or devices are not introduced into the marketplace for patients based on mere intuition or hunches, but rather once their safety and effectiveness has been proven by controlled, scientific studies.

The reason for the success of this approach is that well-designed, controlled studies are vastly superior to the fallible intuitions of doctors based on individual, clinical observations alone. Intuition is subject to several common errors, including bias and overconfidence, and scientific research is needed to check such errors. No matter how compelling they are, inferences can be mistaken. This has been repeatedly confirmed by scientific studies. Hence, under federal law, there must be “substantial evidence” of the safety and effectiveness of any new medical drug or device.

There are numerous examples in medical history where medical innovations — like the routine use of episiotomy during childbirth — were first introduced based on intuition and small studies and then — after prospective, controlled studies — were shown to increase rather than decrease the risk of maternal injury.

Evidence-based medicine has been increasingly adopted in all specialties and areas of medicine — except when it comes to partial-birth abortion (also called D&X). In the early 1990s, partial-birth abortion was an untried alternative to established procedures like medical induction of labor and dilation and evacuation (D&E). Partial-birth abortion was first used on patients based on intuition that it would work safely, but with insufficient evidence of its safety or effectiveness. No empirical studies existed in 1992. None existed in 2000, when the Supreme Court first approved partial-birth abortion. None exists today.

Empirical evidence is particularly important in abortion practice because most abortion clinics don’t do follow-up on abortion patients. Women who suffer short-term complications usually go to a hospital emergency department (ED); they don’t return to the clinic. And EDs typically don’t inquire or report about abortion complications. Consequently, many abortion providers are not aware of the short-term or long-term complications of abortions.

The Supreme Court directly created this dysfunctional abortion system over the past 33 years by eliminating the abortion laws of all 50states, requiring no regulation, and then repeatedly obstructing states’ attempts to regulate abortion.

In 2000, the Supreme Court gave its stamp of approval to partial-birth abortion in the Stenberg case. By a 5-4 vote, the Supreme Court dismissed the need for any empirical evidence showing the value of the procedure, deferred to the intuition of a handful of abortion providers who performed the procedure, and threw out state prohibitions on partial-birth abortion enacted by overwhelming margins in Nebraska and 29 other states.

On November 8, the Supreme Court will revisit the issue, when it hears arguments over the federal Partial-Birth Abortion Ban Act of 2003. These new cases are very different from Stenberg, because they include extensive trial records based on weeks of medical testimony.

This evidence that was presented to the trial courts on the safety and effectiveness of partial-birth abortion was little more than intuition. Consider the objective standards of the U.S. Preventive Services Task Force (USPSTF). The USPSTF evaluates the quality of empirical evidence that is needed before a new medical technique or device can go to market. The USPSTF 2005 Guide to Clinical Preventive Services grades the quality of the overall evidence for a service on a 3-point scale (good, fair, poor). “Poor” evidence is “insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes.”

While the American College of Obstetricians & Gynecologists (ACOG) says that they adhere to USPSTF standards, they have ignored the standards when it comes to partial-birth abortion. The evidence in the cases before the Supreme Court never rose above the “poor” grade.

Realizing the lack of empirical data supporting the safety and effectiveness of partial-birth abortion, the supporters of D&X rushed a study to publication during the court trials. That study was found on several grounds to fall far short of providing reliable evidence for the superiority of the partial birth abortion procedure. The main author admitted that he could not state that D&X was superior to other techniques and that D&X did not avoid the complications to women that often are concurrent when such a procedure is desired. The study found no difference between partial-birth abortion and D&E in procedure time or blood loss.

If evidence-based medicine is thrown out in the case of partial-birth abortion and intuition is to become the standard, intuition shows multiple potential risks from D&X. These include heightened risk of placenta previa in future pregnancies, heightened risk of pre-term birth (PTB or prematurity) in future pregnancies, heightened risk of maternal laceration from crushing the fetal skull or puncturing the fetal neck, increased risk of infection from extended dilation of the cervix, and heightened risk of uterine trauma from internal rotation of the fetus during D&X, which carries risks of uterine rupture, abruption, and trauma to the uterus.

In 2000, the Supreme Court struck down the partial-birth-abortion prohibitions passed by overwhelming majorities in 30 states on the rationale that “division of medical opinion…signals the presence of risk, not its absence.” But risk of what? The records in the new cases show that a division of medical opinion based on intuition, in the absence of empirical evidence, signals uncertainty as towhether D&X involves a greater or lesser risk for women than well-established procedures.

In 1973, the Court struck down the abortion laws of all 50 states, put the burden on the states to regulate the procedure, and then erected barriers to such regulations. The Court’s casual deference to the subjective intuition of abortion providers allows abortion providers to thumb their nose at evidence-based medicine, as they have done since 1973.

Much emphasis has been placed on how partial-birth abortion is really infanticide, and rightly so, but too little attention has been given to how the procedure carries serious potential risks for women. The lack of empirical data to support the safety or effectiveness of the D&X procedure after 15 years justifies the Supreme Court in upholding the federal Partial-Birth Abortion Ban Act and in overturning its 2000 decision in Stenberg, so that the people in the states, through their elected representatives, can re-enact the 30 state prohibitions enacted between 1995-2000.

– Clarke D. Forsythe is the attorney and director of the Project in Law & Bioethics of the Americans United for Life in Chicago.